Brufen

Medicinal product

(Invented) name

Brufen

Active substance (s)

Ibuprofenas

Strength

20 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE01, Ibuprofen

Marketing authorisation holder

Mylan IRE Healthcare Limited, Airija

Date of authorisation

2011-07-20

Date of renewal

2014-11-10

Documents

1885_9_10 Pakuotės lapelis 210305.docx

1885_9_10 Brufen 20mg_ml ger susp PCS PL 210305.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0912/004/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Ibuprofenas	20 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
44496	58290	1058290	buteliukas	100 ml ir geriamasis švirkštas/matavimo šaukštas N1		Receptinis	LT/1/10/1885/009	Netiekiama	-	-	No	-	-	Download
47651	61473	1061473	buteliukas	200 ml ir geriamasis švirkštas/matavimo šaukštas N1		Receptinis	LT/1/10/1885/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-30	Išregistruotas
2014-11-10	Perregistruotas
2011-07-20	Registruotas